Collapsible medical device for atrial sealing and trans-septal access

ABSTRACT

The present disclosure provides collapsible medical devices that may be introduced via a delivery device into a pre-existing patent foramen ovale or trans-septal puncture hole and left in place to provide both a sealing function on the atrial wall and a septal-access function for additional procedures. The disclosed medical devices include a penetrable and re-sealable gasket material disposed in an open lumen in the medical device. This penetrable and re-sealable material allows catheters or other medical devices to pass therethough for providing additional therapy to an individual. By allowing the access point or portal to be opened by a guidewire or another medical tool, the medical devices as disclosed herein may be particularly suitable for a variety of cardiac procedures including, for example, atrial fibrillation, mitral valve replacement or repair, left atrial appendage closures, and the like.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/059,726, filed Aug. 9, 2018, which claim priority to U.S. ProvisionalPatent Application No. 62/543,663, filed Aug. 10, 2017, which areincorporated by reference herein in their entirety.

BACKGROUND OF THE DISCLOSURE a. Field of Disclosure

The present disclosure generally relates to a collapsible medical deviceand methods of making and using the same. In particular, the presentdisclosure relates to a collapsible medical device that seals a patentforamen ovale or trans-septal hole and allows for repeated trans-septalaccess for subsequent medical procedures or therapies. The collapsiblemedical device includes a gasket that is penetrable and re-sealabledisposed in a cylindrical segment of the device that provides both asealing function and an access function. Methods of manufacturing andusing the collapsible medical devices including the gasket are alsodisclosed.

b. Background Art

A wide variety of intravascular medical devices are used in variousmedical procedures within the body. Certain intravascular medicaldevices, such as catheters and guidewires, are generally used simply todeliver fluids or other medical devices to specific locations within apatient's body, such as a selective site within the vascular system.Other, frequently more complex, collapsible intravascular devices areused in treating specific conditions, such as devices used in removingvascular occlusions, for treating septal defects, for valvereplacements, stent introduction, and the like. Many of these morecomplex collapsible intravascular devices are constructed, at least inpart, of a braided tubular member, such as a nitinol braided tubularmember.

SUMMARY OF THE DISCLOSURE

The present disclosure is directed to a collapsible medical device foroccluding a trans-septal hole. The medical device comprises: (i) atubular member formed of a braided fabric having a preset, expandedconfiguration and a collapsed configuration and comprising a proximalend and a distal end, wherein, in the expanded configuration, thetubular member comprises a proximal disc-shaped portion at the proximalend, a distal disc-shaped portion at the distal end, and a cylindricalsegment between the proximal disc-shaped portion and the distaldisc-shaped portion, wherein proximal free wire ends of the braidedfabric extend proximally from the proximal disc-shaped portion anddistal free wire ends of the braided fabric extend distally from thedistal disc-shaped portion, the proximal and distal free wire ends andcylindrical segment collectively defining an open lumen through thetubular member, and (ii) a gasket disposed at least partially within thecylindrical segment, wherein the gasket occupies an entire length of thecylindrical segment and at least a portion of the open lumen defined bythe proximal or distal free wire ends, the gasket sized and configuredto be penetrable and re-sealable.

The present disclosure is also directed to a collapsible medical devicefor occluding a trans-septal hole. The medical device comprises: (i) atubular member formed of a braided fabric having a preset, expandedconfiguration and a collapsed configuration and comprising a proximalend and a distal end, wherein, in the expanded configuration the tubularmember comprises at least one plane of occlusion at the proximal end, atleast one plane of occlusion at the distal end, and a segmenttherebetween, wherein proximal free wire ends of the braided fabricextend proximally from the at least one plane of occlusion at theproximal end and distal free wire ends of the braided fabric extenddistally from the at least one plane of occlusion at the distal end, theproximal and distal free wire ends and the segment collectively definingan open lumen through the tubular member; and (ii) a gasket disposed atleast partially within the segment, wherein the gasket occupies anentire length of the segment and at least a portion of the open lumendefined by the proximal or distal free wire ends, the gasket sized andconfigured to be penetrable and re-sealable.

The present disclosure is further directed to a method of forming acollapsible medical device for occluding a trans-septal hole. The methodcomprises: (i) introducing a braided fabric onto one or more mandrels;(ii) heat-setting the braided fabric on the one or more mandrels to forma structure with a proximal disc-shaped portion at the proximal end anda distal disc-shaped portion at the distal end of the structure and acylindrical segment therebetween, wherein proximal free wire ends of thebraided fabric extend proximally from the proximal disc-shaped portionand distal free wire ends extend distally from the distal disc-shapedportion, the proximal and distal free wire ends and the cylindricalsegment collectively defining an open lumen through the structure; (iii)immobilizing the proximal and distal free wire ends of the structure;(iv) inserting a gasket into the cylindrical segment, wherein, onceinserted, the gasket occupies an entire length of the cylindricalsegment and at least a portion of the open lumen defined by the proximalor distal free wire ends; and (v) securing the gasket to the cylindricalsegment.

The present disclosure is directed to a collapsible medical device foroccluding a trans-septal hole. The medical device comprises: (i) atubular member formed of a braided fabric having a preset, expandedconfiguration and a collapsed configuration and comprising a proximalend and a distal end, wherein, in the expanded configuration, thetubular member comprises a proximal disk-shaped portion at the proximalend, a distal disk-shaped portion at the distal end, and a cylindricalsegment between the proximal disk-shaped portion and the distaldisk-shaped portion; and (ii) a gasket disposed at least partiallywithin the cylindrical segment, wherein the gasket is sized andconfigured to be penetrable and re-sealable.

The present disclosure is further directed to a collapsible medicaldevice for occluding a trans-septal hole. The medical device comprises:(i) a tubular member formed of a braided fabric having a preset,expanded configuration and a collapsed configuration and comprising aproximal end and a distal end, wherein, in the expanded configurationthe tubular member comprises at least one plane of occlusion at theproximal end, at least one plane of occlusion at the distal end, and acylindrical segment therebetween; and (ii) a gasket disposed at leastpartially within the cylindrical segment, wherein the gasket is sizedand configured to be penetrable and re-sealable.

The present disclosure is further directed to a method of forming acollapsible medical device for occluding a trans-septal hole. The methodcomprises: (i) inverting a proximal end of a braided tubular member overitself toward a distal end of the braided tubular member to form astructure having an inner layer and an outer layer, wherein thestructure includes a free wire end; (ii) using one or more mandrels toform the structure to have a proximal disk-shaped portion at theproximal end and a distal disk-shaped portion at the distal end of thestructure and a cylindrical segment therebetween; (iii) immobilizing thefree wire end of the structure; (iv) introducing a gasket into thecylindrical segment; and (v) securing the gasket to the cylindricalsegment.

The present disclosure is further directed to a method of forming acollapsible medical device for occluding a trans-septal hole. The methodcomprises: (i) introducing a braided tubular member onto one or moremandrels and forming a structure having a proximal disk-shaped portionat a proximal end and a distal disk-shaped portion at a distal end ofthe structure and a cylindrical segment therebetween, wherein thestructure includes free wires ends at the proximal end and free wireends at the distal end; (ii) immobilizing the free wire ends at theproximal end and distal end of the structure; (iii) introducing a gasketinto the cylindrical segment; and (iv) securing the gasket to thecylindrical segment.

The foregoing and other aspects, features, details, utilities, andadvantages of the present disclosure will be apparent from reading thefollowing description and claims, and from reviewing the accompanyingdrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a structure of the present disclosureincluding a proximal disk, a distal disk, and a cylindrical segment;

FIG. 1a is a perspective view of a structure of the present disclosureincluding a proximal disk, a distal disk, and a cylindrical segment,wherein the proximal disk and the distal disk are of different sizes;

FIG. 2 is the structure of FIG. 1 shown from the proximal end;

FIG. 3 is a perspective view of a collapsible medical device of thepresent disclosure including a penetrable and re-sealable gasket;

FIG. 4 is the collapsible medical device of FIG. 3 shown from theproximal end;

FIG. 5 is a perspective view of a collapsible medical device of thepresent disclosure including free wire ends on a proximal and a distalend;

FIG. 6 is the collapsible medical device of FIG. 5 where the free wireends on the proximal and distal end have been trimmed;

FIGS. 7A, 7B, 8A, and 8B are flow diagrams of methods of formingcollapsible medical devices including a penetrable and re-sealablegasket;

FIGS. 9A and 9B are flow diagrams of a method for crossing thetrans-septal wall of an individual.

DETAILED DESCRIPTION OF THE DISCLOSURE

Many cardiac procedures in use today are utilizing a trans-septalapproach to deliver a particular medical device and/or one more types ofcardiac therapies. If the individual being treated does not have apatent foramen ovale and a trans-septal puncture is needed for thedesired access, the individual is left with a hole in the septum afterthe procedure, which could result in undesirable blood or blood clotcrossover if not addressed properly. Further, if the individual requiresan additional procedure or procedures in the future that requiretrans-septal access, an additional puncture may ultimately be required.As such, it would be beneficial to provide the individual with a medicaldevice that could seal any trans-septal puncture hole or patent foramenovale, yet allow for future trans-septal access for procedures soadditional punctures would not be required or prevented by an occlusivedevice lacking an access point.

The present disclosure is directed to a collapsible medical device thatmay be introduced via a delivery catheter or other suitable medicaldelivery device into a pre-existing patent foramen ovale, trans-septalpuncture hole, or the like and left in place to provide both a sealingfunction on the atrial wall and a septal-access function for additionalprocedures. That is, in addition to providing a desired sealing functionto prevent blood clots from transferring across the atrial wall, thepresently disclosed medical devices provide an access point or “portal”for crossing the trans-septal wall using a penetrable and re-sealablegasket material disposed in an open lumen in the collapsible medicaldevice. This penetrable and re-sealable access point including thegasket material allows needles, catheters or other medical devices topass therethough for providing additional therapy to an individual. Byallowing the access point or portal to be opened by a guidewire oranother medical tool, the medical devices as disclosed herein may beparticularly suitable for a variety of cardiac procedures including, forexample, atrial fibrillation, mitral valve replacement or repair, leftatrial appendage closures, and the like.

The collapsible medical devices of the present disclosure including thepenetrable and re-sealable gasket provide a user with a number ofadvantages. These devices create a pathway that can be utilized formultiple separate procedures at different times without the need toperform a trans-septal puncture each time, while providing a secureanchoring of the device in the desired position. Further, these devicescan be manufactured in a wide variety of sizes (in a collapsible state)of from about 8 F to about 27 F to accommodate a range of end users andmay include planes of occlusion as described herein (in an expandedstate) of from about 4 millimeters to about 40 millimeters in size.

The collapsible medical devices of the present disclosure are formedfrom one or more layers of a tubular member formed of a braided fabricthat comprises a plurality of wires generally configured tosubstantially occlude blood flow. The tubular member is generally formedof woven metal wires or strands that are heat set after formation intothe desired configuration as more fully described below. The woven metalwires are a plurality of conventional wires that have a predeterminedrelative orientation between the wires. The wires define two sets ofessentially parallel generally helical stands, with the strands of oneset having a “hand”, i.e., a direction of rotation, opposite that of theother set. These helical wires define a generally tubular metal fabric,known in the metal fabric industry as a tubular braid.

The pitch of the wires (i.e., the angle defined between the turns of thewire and the axis of the braid) and the pick of the fabric (i.e., thenumber of wire crossovers per unit length) may be adjusted as known bythose of skill in the art based on the disclosure herein toincrease/decrease/optimize the rigidity/strength as desired for aparticular application. The wires of the metal fabric used to constructthe collapsible medical devices described herein are desirably formed ofa material that is both resilient and that can be heat treated tosubstantially set a desired shape. Materials that are suitable for thispurpose include a cobalt-based low thermal expansion alloy referred toin the field as Elgeloy, nickel-based high temperature high-strengthsuperalloys commercially available from Haynes International under thetrade name Hastelloy, nickel-based heat treatable alloys sold under thename Incoloy by International Nickel, and a number of different gradesof stainless steel. An important factor in choosing a suitable materialfor the wires is that the wires retain a suitable amount of thedeformation induced by a molding process when subjected to apredetermined heat treatment.

One class of materials that are desirable is memory-shape alloys. Suchalloys tend to have a temperature induced phase change that will causethe material to have a preferred configuration that can be fixed byheating the material above a certain transition temperature to induce achange in the phase of the material. When the alloy is cooled back down,the alloy will “recall” the shape it was in during the heat treatmentand will tend to assume that configuration unless constrained from doingso.

One particularly desirable memory shape alloy for use in the presentdisclosure is nitinol, an approximately stoichiometric alloy of nickeland titanium, which may also include minor amounts of other metals toachieve desired properties. Nickel-titanium alloys are very elastic andare commonly referred to as “superelastic” or “pseudoelastic.” Theelasticity of these alloys helps a medical device return to an expandedconfiguration for deployment inside of the body following passage in adistorted or collapsed form through a delivery catheter. Nitinol is aparticularly desirable alloy for forming the collapsible medical devicesof the present disclosure.

The metal wires used to fabricate the collapsible medical devices of thepresent disclosure may include wires having a diameter of from about0.002 to about 0.008 inches (about 0.051 to about 0.203 millimeters),including from about 0.002 to about 0.005 inches (about 0.051 to about0.127 millimeters). In some embodiments the wires have a diameter offrom about 0.003 to about 0.0035 inches (about 0.076 to about 0.089millimeters), and in some other embodiments, about 0.003 inches (about0.076 millimeters). In one specific embodiment, the wires have adiameter of about 0.006 inches (about 0.152 millimeters). The number ofwires in a wire mesh fabric (or tubular braid) may vary from about 36 toabout 144, desirably from about 72 to about 144, and in someembodiments, 144. The pick count of the wire mesh may vary from about 30to about 100, including from about 50 to about 80, including 70. Asnoted above, the wire diameter and the number of wires in the wire meshfabric will tend to influence the rigidity, strength, and flexibility ofthe resulting collapsible medical device. Numerous other embodiments andcombinations of wires sizes are contemplated within the scope of thisdisclosure.

In one specific embodiment of the present disclosure, a collapsiblemedical device including a penetrable and re-sealable gasket is formedfrom a tubular member formed of a braided fabric (such as a braidednitinol tube) by first inverting a proximal end of the braided fabricover itself toward a distal end thereof to form a structure having aninner layer and an outer layer. In this embodiment, the inversioncreates a dual layer structure that includes only a single set of freewire ends; that is, one end of structure is smooth and contains no freewire ends due to the inversion. Also disclosed and discussed hereinbelowis an alternative embodiment wherein a single layer or dual layerstructure is created that includes free wire ends on both the proximaland the distal ends of the structure.

Once this dual layer structure including a single free wire end has beenformed, it is introduced onto one or more mandrels and heat-set and/orheat-treated to shape and form the structure into the desired end form.In many embodiments of the present disclosure, the dual layer structurewill be formed by the mandrel(s) to have a proximal disk-shaped portionat the proximal end and a distal disk-shaped portion at the distal endwith a geometrical shaped segment or portion (sometimes referred to as a“waist”) therebetween. This structure will include one set of free wireends (open end of the braided structure), as discussed above, generallyon the proximal end. In many embodiments, the geometrical shaped portionbetween the proximal disk-shaped portion and the distal disk-shapedportion may be a cylindrical segment or portion. The proximaldisk-shaped portion and distal disk-shaped portion may be the same size,substantially the same size, or may be different sizes. Alternatively,in other embodiments, the proximal portion and the distal portion havingthe geometrical shaped segment therebetween may be geometrical shapesother than disks; the exact geometrical shape of the proximal portionand the distal portion is not critical, so long as they both provide aplane of occlusion and a secure fit. Although many of the embodimentsdisclosed and discussed herein refer to a proximal disk-shaped portionand a distal disk-shaped portion having a cylindrical segmenttherebetween, these portions and segment can be formed of any suitablegeometrical shape that provides the intended benefit to the resultingmedical device. In some embodiments, the proximal portion and the distalportion may be customized for an individual user based on a computerizedtomography scan or other scan or procedure of the individual user.

Once the structure having the proximal disk-shaped portion at theproximal end and the distal disk-shaped portion at the distal end andthe cylindrical segment therebetween has been formed using the mandrelsand suitable heat treatment process, the free wires present on theproximal end of the structure are immobilized using a securementmechanism to ensure that the braided fabric does not unravel. Theimmobilization of the free wires may be done using any number of methodsor securement mechanisms known in the art including, for examplewelding, soldering, brazing, heat shrink tubing, coating, gluing, tying,or affixing the ends together with a biocompatible cementitious organicmaterial. In one desirable embodiment, the free wires may be immobilizedby reflowing one or more materials over the free wires and allowing thereflowed material to harden. Suitable reflow materials include, forexample, thermoplastic materials, with urethanes and polyether blockamides (PEBAX®) being desirable materials. In many embodiments, the freewires will be immobilized and shaped such that an additional componentmay be introduced into the shaped hole or around the shaped hole tofacilitate delivery of the medical device ultimately formed from thestructure; that is, the free wires may be immobilized and shaped toallow a nut to be introduced into the formed hole so that a suitabledelivery device could be attached to the nut for delivery of the medicaldevice. In some embodiments, the nut, or another ring or other componentor the free wires ends may be fabricated from a material (or coated witha material) that is radiopaque to facilitate guidance of the medicaldevice during placement in a procedure. In some embodiments, the nut orother component may be introduced into the formed opening or hole priorto the reflowing of a material such that the reflowing of the materialmay immobilize the free wire ends and secure the nut or other componentin place. In other embodiments, the free wire end may be trimmed orotherwise removed altogether so as to produce a flush end.

Referring now to FIG. 1, there is shown medical device 2 includingproximal end 4 and distal end 6. Proximal end 4 includes proximal disk 8and free wire ends 10 immobilized by coating 12. Distal end 6 includesdistal disk 14. Located between proximal disk 8 and distal disk 14 iscylindrical segment 16. Although illustrated in FIG. 1 as two disks,proximal disk 8 and distal disk 14 could be any suitable geometric shapeor shapes, as noted above.

Referring now to FIG. 1a , there is shown medical device 2 includingproximal end 4 and distal end 6. Proximal end 4 includes proximal disk 8and free wire ends 10 immobilized by coating 12. Distal end 6 includesdistal disk 14. Located between proximal disk 8 and distal disk 14 iscylindrical segment 16. Proximal disk 8 and distal disk 14 are differentsizes.

Referring now to FIG. 2, there is shown a proximal end view of thestructure of FIG. 1. Medical device 2 includes proximal end 4 and distalend 6. Proximal end 4 includes proximal disk 8 and free wire ends 10immobilized by coating 12. Distal end 6 includes distal disk 14 having acontinuous surface with no wire ends. Proximal end 4 additionallyincludes nut 18 located within free wire ends 10 for attaching anothermedical device (not shown) to medical device 2.

Once the free wires have been immobilized on the structure, a gasket isintroduced into at least a portion of the cylindrical segment. Thegasket is sized and configured to substantially occupy at least aportion of the cylindrical segment and provide a substantially tight fitwithin the structure that can provide the desired sealing function. Thegasket may be introduced into the cylindrical segment such that thegasket occupies the entire length of the cylindrical segment, or only apart of the cylindrical segment; that is, the gasket may or may notcompletely fill the entire length of the cylindrical segment.Additionally, the gasket may or may not extend into and occupy part orall of the opening created by the immobilized wire ends; that is, thegasket may or may not extend into and occupy all or a portion of thecylindrical segment and part or all of the opening created by theimmobilization of the wire ends.

The gasket is introduced into cylindrical segment of the structure toprovide a sealing (and re-sealing after puncture) function as well asaccess through the structure; that is, the gasket seals the structure sothat liquid cannot pass through while simultaneously providing apenetrable portal through which another medical device, such as aneedle, catheter, or introducer may pass through without the sealingfunction of the disks or cylindrical segment being compromised. Theother medical device, such as a needle, may also be withdrawn from thecylindrical segment at which time the gasket re-seals itself.

The gasket may be comprised of a single material, or it may be comprisedof one or more materials such that it is a multi-part or multi-componentgasket. It may be a single layer gasket, or it may be comprised ofmultiple layers. In some embodiments, the gasket may have a uniformdensity throughout, while in other embodiments the density of the gasketmay change such that the gasket comprises zones of varying density. Insome embodiments, all or one or more portions of the gasket may includeone or more antithrombogenic coatings thereon to deter the formation oftissue or blot clots thereon. Additionally, the gasket may optionallyinclude one or more pre-cut slits therein to facilitate penetrationtherethough by another medical device.

The gaskets for use in the present disclosure are generally formed froma self-sealing or self-healing material; that is, the gaskets aregenerally formed from one or more materials that are penetrable but thatre-seal or re-close after the penetration is removed. Any number ofsuitable materials may be used to form the gasket including, forexamples, polymers, silicone-based materials, soft thermoplastics, andthe like. The exact material used to form the gasket is not critical, solong as it provides the desired penetrable and re-sealablecharacteristics described herein.

Once the gasket is positioned within the structure at the desiredlocation within at least a portion of the cylindrical segment, thegasket may be stabilized and immobilized therein to ensure that thegasket remains in the desired location and is not substantially mobilewithin the structure. In one specific embodiment, the gasket isstabilized and immobilized within the structure by introducing one ormore sutures through the tubular member of braided fabric and throughthe gasket such that the fabric and gasket are sutured together. Anynumber of sutures can be used for the stabilization and immobilizationof the gasket. Other means of stabilizing and immobilizing the gasketmay also be used in accordance with the present disclosure including forexample, bonding, gluing, and the like.

Referring now to FIG. 3, there is shown a collapsible medical device inaccordance with one embodiment of the present disclosure. Collapsiblemedical device 20 includes proximal end 4 and distal end 6. Proximal end4 includes proximal disk 8 and free wire ends 10 immobilized by coating12. Distal end 6 includes distal disk 14. Located between proximal disk8 and distal disk 14 is cylindrical segment 16. Disposed withincylindrical segment 16 is gasket 22. Gasket 22 is attached tocylindrical segment 16 with sutures 23.

Referring now to FIG. 4, there is shown a proximal end view ofcollapsible medical device 20 of FIG. 3. Collapsible medical device 20includes proximal disk 8 and gasket 22 disposed within the cylindricalsegment 16.

In an alternative embodiment of the present disclosure, a collapsiblemedical device including a penetrable and re-sealable gasket asdescribed above is formed from a single layer of a tubular member formedof a braided fabric (such as a braided nitinol tube) or a double layerof a tubular member formed of a braided fabric (one tubular memberinside of another tubular member) without any inversion; that is, inthis alternative embodiment, the tubular member or members formed of abraided fabric is not first inverted over itself as described above tocreate a dual layer structure. In this alternative embodiment, a singlelayer or a double layer structure is formed that includes two sets offree wire ends (two open ends of the braided fabric); one set on theproximal end, and one set on the distal end. This single layer or doublelayer of braided fabric including two sets of free wire ends is firstintroduced onto one or more mandrels and heat-set and/or heat-treated toshape and form the desired structure as set forth above. For example, inone embodiment, the single layer or double layer of braided fabric maybe formed on the one or more mandrels to include a proximal disk-shapedportion at the proximal end, a distal disk-shaped portion at the distalend, and a cylindrical segment therebetween.

Once the structure having the proximal disk-shaped portion at theproximal end and the distal disk-shaped portion at the distal end andthe cylindrical segment therebetween has been formed using the mandrelsand suitable heat treatment process, the free wires present on theproximal end and the distal end are immobilized as described above toensure that the fabric does not unravel at the proximal and distal ends.The same or different immobilization techniques may be used on each ofthe proximal and distal ends of the structure.

After the free wires have been immobilized on the proximal and distalends of the structure, a gasket is introduced into at least a portion ofthe cylindrical segment as described above. The gasket is sized andconfigured to substantially occupy at least a portion of the cylindricalsegment and provide a substantially tight fit within the structure thatcan provide the desired sealing function.

Referring now to FIG. 5, there is shown a collapsible medical device 24formed in accordance with this alternative embodiment wherein a singlelayer of braided fabric is utilized. Collapsible medical device 24includes proximal end 26 and distal end 28. Proximal end 26 includesproximal disk 30 and free wire ends 32 immobilized by coating 34. Distalend 28 includes distal disk 36 and free wire ends 38 immobilized bycoating 40. Located between proximal disk 30 and distal disk 36 iscylindrical segment 42. Disposed within cylindrical segment 42 is gasket44. Gasket 44 is attached to cylindrical segment 42 with sutures 46.

As noted above, in some embodiments of the present disclosure, the freewire end or ends on the collapsible medical device may be trimmed orotherwise removed altogether to reduce the overall profile of theresulting collapsible medical device, which may be advantageous in someembodiments where overall size is of concern. Such trimming may beaccomplished by any means known to one of ordinary skill in the art solong as the remaining structure after the trimming is not subject tounraveling. Referring now to FIG. 6, there is shown one embodiment of acollapsible medical device of the present disclosure wherein the freewire ends on both the proximal end and the distal end have been trimmedaway. Collapsible medical device 50 includes proximal end 52 and distalend 54. Proximal end 52 includes proximal disk 56. Distal end 54includes distal disk 58. Located between proximal disk 56 and distaldisk 58 is cylindrical segment 60. Disposed within cylindrical segment60 is gasket 62. Gasket 62 is attached to cylindrical segment 60 withsutures 64.

FIGS. 7A and 7B are flow diagrams of a method 100 for forming acollapsible medical device (such as collapsible medical device 20 shownin FIG. 3) including a penetrable and re-sealable gasket (such as gasket22 shown in FIG. 3) for occluding a trans-septal hole, according to oneembodiment. Method 100 includes inverting 102 a first (e.g. proximal)end of braided tubular member over itself toward a second (e.g. distal)end of the braided tubular member to form a structure having an innerlayer, an outer layer, and a free wire end. Method 100 further includesforming 104 the structure to have a proximal disk-shaped portion at aproximal end and a distal disk-shaped portion at a distal end of thestructure and a cylindrical segment therebetween (e.g. by using amandrel). Method 100 further includes immobilizing 106 the free wire endof the structure. Method 100 further includes optionally trimming 108the immobilized free wire end to a desired length. Method 100 furtherincludes introducing 110 a gasket into the cylindrical segment andoptionally securing 112 the gasket to the cylindrical segment. Finally,method 100 optionally includes attaching 114 an anchoring mechanism tothe structure for interfacing with a medical delivery device.

FIGS. 8A and 8B are flow diagrams of a method 200 for forming acollapsible medical device (such as collapsible medical device 24 shownin FIG. 5) including a penetrable and re-sealable gasket (such as gasket44 shown in FIG. 5) for occluding a trans-septal hole, according to oneembodiment. Method 200 includes introducing 202 a braided tubular memberonto one or more mandrels and forming 204 a structure having a proximaldisk-shaped portion at a proximal end, a distal disk-shaped portion at adistal end, a cylindrical segment therebetween, with free wire endslocated at the proximal end and free wire ends located at the distal endof the structure. Method 200 further includes immobilizing 206 the freewire ends at the proximal and distal ends of the structure. Method 200further includes optionally trimming 208 the immobilized free wire endsto a desired length. Method 200 further includes introducing 210 agasket into the cylindrical segment and optionally securing 212 thegasket to the cylindrical segment. Finally, method 200 optionallyincludes attaching 214 an anchoring mechanism to the structure forinterfacing with a medical delivery device.

As noted herein, the collapsible medical devices of the presentdisclosure including the penetrable and re-sealable gasket provide anaccess point or “portal” for crossing the trans-septal wall onceintroduced and deployed at a desired location within the body. In oneexemplary embodiment of the present disclosure, the collapsible medicaldevice is introduced into a pre-existing patent foramen ovale ortrans-septal puncture hole and deployed as discussed herein such thatthe disks (or other planes of occlusion) present on the distal andproximal ends of the collapsible medical device, as well as thepenetrable and re-sealable gasket, seal the patent foramen ovale ortrans-septal puncture hole. Once the collapsible medical deviceincluding the penetrable and re-sealable gasket as described herein hasbeen deployed, access across the septum (for further therapies and suchas described herein) may be obtained by first locating and contactingthe gasket with a guide catheter or similar delivery device andadvancing a trans-septal puncture needle or equivalent through the guidecatheter and through the length of the gasket. Once the trans-septalpuncture needle has been advanced through the gasket, the guide cathetermay be advanced over the trans-septal puncture needle and through thegasket. The needle may then be retracted resulting in the open guidecatheter providing access across the collapsible medical device (andhence across the trans-septal wall) via the penetrable and re-sealablegasket. Additional medical devices and/or therapies may then beintroduced through the guide catheter and across the trans-septal wallwithout the need for an additional trans-septal puncture hole. Once theadditional medical devices and/or therapies have been used, they may beretracted out of the guide catheter and the guide catheter removed fromthe gasket. After the guide catheter is removed, the penetrable andre-sealable gasket will reseal itself and provide its desired sealingfunction while allowing for additional trans-septal access.

FIGS. 9A and 9B are flow diagrams of a method 300 for providing accessacross the trans-septal wall of an individual. Method 300 includesintroducing 302 a collapsible medical device including two planes ofocclusion and a penetrable and re-sealable gasket into a pre-existingpatent foramen ovale or trans-septal puncture hole and deploying 304 thecollapsible medical device to seal the patent foramen ovale ortrans-septal puncture hole. Method 300 further includes locating 306 thepenetrable and re-sealable gasket with a guide catheter and contacting308 the penetrable and re-sealable gasket with the guide catheter.Method 300 further includes advancing 310 a trans-septal puncture needlethrough the guide catheter and through the gasket. Method 300 furtherincludes advancing 312 the guide catheter over the trans-septal punctureneedle and retracting 314 the trans-septal puncture needle to provideaccess across the trans-septal wall. In some embodiments, steps 306,308, 310, 312, and 314 may be completed in a method separate and apartfrom steps 302 and 304; that is, they may be completed in a separateprocedure by the same or a different operator.

Although a number embodiments of this disclosure have been describedabove with a certain degree of particularity, those skilled in the artcould make numerous alterations to the disclosed embodiments withoutdeparting from the spirit or scope of the disclosure. All directionalreferences (e.g., upper, lower, upward, downward, left, right, leftward,rightward, top, bottom, above, below, vertical, horizontal, clockwise,and counterclockwise) are only used for identification purposes to aidthe reader's understanding of the present disclosure, and do not createlimitations, particularly as to the position, orientation, or use of thedisclosure. Joinder references (e.g., attached, coupled, connected, andthe like) are to be construed broadly and may include intermediatemembers between a connection of elements and relative movement betweenelements. As such, joinder references do not necessarily infer that twoelements are directly connected and in fixed relation to each other. Itis intended that all matter contained in the above description or shownin the accompanying drawings shall be interpreted as illustrative onlyand not limiting. Changes in detail or structure may be made withoutdeparting from the spirit of the disclosure as defined in the appendedclaims.

Any patent, publication, or other disclosure material, in whole or inpart, that is said to be incorporated by reference herein isincorporated herein only to the extent that the incorporated materialsdoes not conflict with existing definitions, statements, or otherdisclosure material set forth in this disclosure. As such, and to theextent necessary, the disclosure as explicitly set forth hereinsupersedes any conflicting material incorporated herein by reference.Any material, or portion thereof, that is said to be incorporated byreference herein, but which conflicts with existing definitions,statements, or other disclosure material set forth herein will only beincorporated to the extent that no conflict arises between thatincorporated material and the existing disclosure material.

What is claimed is:
 1. A collapsible medical device for occluding atrans-septal hole comprising: a tubular member formed of a braidedfabric having a preset, expanded configuration and a collapsedconfiguration and comprising a proximal end and a distal end, wherein,in the expanded configuration, the tubular member comprises a proximaldisc-shaped portion at the proximal end, a distal disc-shaped portion atthe distal end, and a cylindrical segment between the proximaldisc-shaped portion and the distal disc-shaped portion, wherein proximalfree wire ends of the braided fabric extend proximally from the proximaldisc-shaped portion and distal free wire ends of the braided fabricextend distally from the distal disc-shaped portion, the proximal anddistal free wire ends and cylindrical segment collectively defining anopen lumen through the tubular member; and a gasket disposed at leastpartially within the cylindrical segment, wherein the gasket occupies anentire length of the cylindrical segment and at least a portion of theopen lumen defined by the proximal or distal free wire ends, the gasketsized and configured to be penetrable and re-sealable.
 2. Thecollapsible medical device of claim 1, wherein the tubular member isformed from a single layer of braided fabric.
 3. The collapsible medicaldevice of claim 1, wherein the open lumen is concentric with theproximal and distal disc-shaped portions.
 4. The collapsible medicaldevice of claim 1, further comprising: a securement mechanism on atleast one of the proximal or the distal end of the tubular member. 5.The collapsible medical device of claim 4, wherein the securementmechanism comprises a reflowed polyether block amide.
 6. The collapsiblemedical device of claim 1, wherein the gasket is secured to thecylindrical segment using one or more sutures.
 7. The collapsiblemedical device of claim 1, wherein the gasket is comprised of asubstantially self-sealing material.
 8. The collapsible medical deviceof claim 7, wherein the substantially self-sealing material issilicone-based.
 9. The collapsible medical device of claim 1, whereinthe gasket includes an antithrombogenic coating thereon.
 10. Thecollapsible medical device of claim 1, wherein the gasket has a uniformdensity.
 11. The collapsible medical device of claim 1, wherein thegasket has a non-uniform density.
 12. The collapsible medical device ofclaim 1, wherein the proximal disc-shaped portion and the distaldisc-shaped portion are substantially the same size.
 13. The collapsiblemedical device of claim 1, wherein the proximal disc-shaped portion andthe distal disc-shaped portion are different sizes.
 14. The collapsiblemedical device of claim 1, wherein the proximal end comprises at leastone anchoring mechanism sized and configured to interface with adelivery device.
 15. A collapsible medical device for occluding atrans-septal hole comprising: a tubular member formed of a braidedfabric having a preset, expanded configuration and a collapsedconfiguration and comprising a proximal end and a distal end, wherein,in the expanded configuration the tubular member comprises at least oneplane of occlusion at the proximal end, at least one plane of occlusionat the distal end, and a segment therebetween, wherein proximal freewire ends of the braided fabric extend proximally from the at least oneplane of occlusion at the proximal end and distal free wire ends of thebraided fabric extend distally from the at least one plane of occlusionat the distal end, the proximal and distal free wire ends and thesegment collectively defining an open lumen through the tubular member;and a gasket disposed at least partially within the segment, wherein thegasket occupies an entire length of the segment and at least a portionof the open lumen defined by the proximal or distal free wire ends, thegasket sized and configured to be penetrable and re-sealable.
 16. Thecollapsible medical device of claim 15, wherein the gasket is secured tothe segment using one or more sutures.
 17. The collapsible medicaldevice of claim 15, wherein the gasket is comprised of a substantiallyself-sealing material.
 18. The collapsible medical device of claim 15,wherein the gasket includes an antithrombogenic coating thereon.
 19. Amethod of forming a collapsible medical device for occluding atrans-septal hole, the method comprising: introducing a braided fabriconto one or more mandrels; heat-setting the braided fabric on the one ormore mandrels to form a structure with a proximal disc-shaped portion atthe proximal end and a distal disc-shaped portion at the distal end ofthe structure and a cylindrical segment therebetween, wherein proximalfree wire ends of the braided fabric extend proximally from the proximaldisc-shaped portion and distal free wire ends extend distally from thedistal disc-shaped portion, the proximal and distal free wire ends andthe cylindrical segment collectively defining an open lumen through thestructure; immobilizing the proximal and distal free wire ends of thestructure; inserting a gasket into the cylindrical segment, wherein,once inserted, the gasket occupies an entire length of the cylindricalsegment and at least a portion of the open lumen defined by the proximalor distal free wire ends; and securing the gasket to the cylindricalsegment.
 20. The method of claim 19, further comprising: attaching tothe device at least one anchoring mechanism sized and configured tointerface with a delivery device.